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November 20, 2023 Big Pharma News

Big Pharma

Moderna Halts Epstein-Barr mRNA Vaccine Trial After Myocarditis Case

Moderna halted its Phase 1 trial of an mRNA vaccine to treat the Epstein-Barr virus after a single suspected case of myocarditis in an adolescent, raising questions about the heart-damaging technology used in all mRNA vaccines, according to a report by Alex Berenson.

moderna vaccine ebv mrna risk feature

Investigators halted a Moderna trial of a new mRNA vaccine for Epstein-Barr virus (EBV) after a participant developed suspected myocarditis, according to independent journalist Alex Berenson.

Moderna paused the Phase 1 “Eclipse” trial following “an urgent communication” from the company overseeing the trial stating that the adverse event “necessitates an immediate suspension of all dosing for ALL adolescents,” Berenson reported.

A person not employed by Moderna provided the communication to Berenson, a former New York Times reporter and author of 13 books.

The case “will only add to the concerns around mRNA biotechnology and heart issues, particularly myocarditis,” Berenson wrote on Substack. The Moderna and Pfizer mRNA COVID-19 vaccines have been linked to myocarditis, especially in young, healthy males.

Moderna did not disclose the trial halt in public filings, according to Berenson, who suggested financial motivations may be behind the lack of transparency after the company told investors this vaccine was one of several expected to generate billions of dollars.

Moderna’s stock price has dropped nearly 85% from its 2021 highs but still remains one of the most valuable biotech companies with a $30 billion market value.

The mRNA platform remains the problem

Berenson said the news around the EBV vaccine, which “uses essentially the same design as Moderna’s Covid shot … a strand of modified mRNA surrounded by a tiny fat globule called a ‘lipid nanoparticle’ or LNP,” raises questions about the entire mRNA platform.

He noted that there is lingering uncertainty about whether it’s the spike protein or the lipid nanoparticles used to encapsulate the modified mRNA that causes myocarditis in people who receive the COVID-19 vaccine.

Myocarditis involves inflammation of the myocardium or heart muscle that can lead to cardiac arrest and death. Symptoms can include chest pain, fatigue, difficulty breathing, fever, rash, exercise intolerance and abnormal heart rhythms.

For the COVID-19 vaccines, the observed risk for myocarditis is higher in teenagers and young people than in older adults, according to Berenson.

Berenson referenced a study published in Nature Immunology showing how lipid nanoparticle-formulated mRNA can suppress certain forms of interleukin 1, which can induce elevated cytokine levels and create excessive inflammation.

A March 2022 paper published in Elsevier’s Metabolism Open explored the possible connection between lipid nanoparticles and myocarditis arising from a non-mRNA vaccine.

A 2016 mouse study of mRNA delivered in lipid nanoparticles showed “activity was detectable in the liver, demonstrating systemic spread of the nanoparticles.”

Numerous other studies have linked the COVID-19 mRNA shots to myocarditis.

In June, Berenson reported on the South Korean study of 12 mRNA-driven myocarditis deaths in young adults and nine deaths in adults over 60. The overall vaccine-related myocarditis rate was about 1 in 100,000, with nearly 20% of those cases rated as severe.

The highest rate was reported for males between the ages of 12-17 — 5.29 cases per 100,000. Autopsies revealed a specific inflammatory signature of lymphohistocytes in the myocardium.

Six cases of myocarditis following the administration of the Pfizer mRNA vaccine were reported in a study published in the May 2021 issue of Vaccine, and eight cases of myocarditis were reported in a paper published in the June 2021 issue of Circulation.

Dr. Peter McCullough on Nov. 4 wrote on Substack that the comparative risks of myocarditis and pericarditis with mRNA, adenoviral DNA and spike antigen vaccines, finding that all of these vaccines carried some risk.

Lack of transparency of mRNA-myocarditis link goes back to 2021

Berenson suggested Moderna’s lack of transparency echoed previous controversies related to myocarditis risk and mRNA vaccines. He referenced research Israel shared on Feb. 28, 2021 warning of myocarditis cases following Pfizer’s COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) was slow to alert the public to this safety signal.

Berenson also claimed the U.S. Department of Defense (DOD) and the Israeli health ministry had identified higher-than-expected myocarditis cases after mRNA vaccination by spring 2021. He reported the DOD shared data with the CDC at closed meetings that were not promptly disclosed to the public by the CDC.

A Sept. 17 report by The Epoch Times referenced a March 9, 2021, U.S. government memorandum discussing 27 cases of myocarditis/peri-myocarditis in the U.S. from a Feb. 23 review of adverse events, but stated “missing and incomplete data make it challenging to assess causation.”

The report stated the CDC met with DOD officials twice behind closed doors in April 2021, where military patient data suggested “myocarditis was indeed a possible side effect” of the mRNA vaccines.

By April 2021, the CDC had received at least 141 reports of myocarditis in the Vaccine Adverse Event Reporting System, or VAERS, database, according to The Epoch Times. However, on April 27, 2021, then-CDC Director Rochelle Walensky during a White House briefing denied this, saying “we have not seen any reports” of myocarditis after vaccination in VAERS, but she did admit to ongoing investigations of the DOD report.

Albert Benavides, an HMO claims auditor and data analyst who created the VaersAware dashboards, told The Defender that as of Oct. 27, 2023, 5,711 children 0-17 years old have a report of “myo/pericarditis & chest pain” listed in VAERS, with about 43.8% (2,504/5,711) of these “hidden away in the ‘UNKNOWN’ age bucket.”

“This crude but very accurate observation indicates that a very high amount of ’UNK’ [unknown] age kids with properly documented summary narratives, also have a disproportionately high amount of heart problems,” Benavides said.

Benavides’ assessment of missing age data in VAERS was reviewed by bioinformatics researcher Herve Seligmann and published on ResearchGate in July, where the two concluded:

“Biases for missing information increase as a function of event severity and decrease with age. Tendencies for increased bias in missing information with event severity are greatest in children, and decrease with age. Pre-and post-screening biases in female/male ratios increase with event severity for ages above 17, the pattern is strongest at peak female fertility ages, 18-29.

“No form adapted to include data of both pregnant women and their un- or newborn child exists, suggesting a systemic, in addition to systematic, maladministration of the VAERS information database.”

EBV linked to multiple malignancies

Moderna began its trial for the mRNA-1189 EBV vaccine in January 2022, when it enrolled around 270 participants between the ages of 18 and 30. Only later did it expand to Phase 1 part B, to include adolescents as young as 12.

Anyone with a history of myocarditis or pericarditis was explicitly excluded from participating in the trial.

The mRNA-1189 vaccine “contains four mRNAs that encode EBV envelope glycoproteins (gH, gL, gp42, gp220), which mediate viral entry into B cells and epithelial surface cells, the major targets of EBV infection,” according to European Pharmaceutical Review.

In Phase 1 trials, drugs are primarily evaluated for their safety rather than their efficacy, Berenson stated.

EBV is a common viral infection typically contracted in early childhood or adolescence and is often asymptomatic. However, it can lead to infectious mononucleosis, a clinical syndrome that can include fever, fatigue, sore throat and lymphadenopathy.

More serious cases of infectious mononucleosis can debilitate patients for weeks or months and can lead to splenic rupture and significant airway compromise.

Moderna’s mRNA-1189 vaccine aims to prevent the development of infectious mononucleosis and EBV infection.

Moderna is developing another EBV vaccine, mRNA-1195, to prevent long-term EBV sequelae.

One of a number of companies working on EBV vaccines, Moderna in its April investor overview links EBV to multiple sclerosis and “EBV-related malignancies.”

According to the BMJ Open paper cited in the investor overview, EBV is a common virus, infecting over 90% of the population, with the virus persisting and B cells for life.

The virus has four “latency programs,” meaning it can come back into active expression in a variety of ways, and has been linked to Burkitt lymphoma, nasopharyngeal carcinoma, Hodgkin lymphoma, gastric carcinomas and other cancers.

EBV also been linked to Guillain-Barré syndrome.

Moderna CEO Stéphane Bancel called the EBV study a “significant milestone as we continue to advance mRNA vaccines against latent viruses, which remain in the body for life after infection and can lead to chronic medical conditions,” according to European Pharmaceutical Review.

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